Quality standards and regulations for plant extracts

Plant extracts are products made from plants as raw materials, which are extracted and separated by physico-chemical methods to obtain and concentrate a specific active ingredient or ingredients without altering their structural properties.

With regard to EU regulations and standards, the European Union has formulated a series of regulations on the production and quality control of plant extracts. The European Pharmacopoeia and the European Chemicals Agency (ECHA) have specialised in the regulation of botanical extracts. For this reason, botanical extracts must strictly comply with EU regulations and obtain European Pharmacopoeia certification.

The US Food and Drug Administration closely regulates the safety and efficacy of botanical extracts under US FDA regulations. The agency establishes separate specifications for each drug product and requires strict adherence to these specifications for production and quality control. If plant extracts are to be marketed and sold in the U.S., they must be approved by the FDA, or they will be considered illegal.

In China, the State Food and Drug Administration (SFDA) regulates botanical extracts in a similarly strict manner. Imported plant extracts are subject to customs inspection and quarantine by the People’s Republic of China and must comply with relevant national standards. In addition, according to the Measures for the Administration of Registration of Imported Drugs, imported plant extracts are also subject to the necessary registration and filing in the Chinese market.

In summary, the regulatory requirements for plant extracts are very strict in all countries and require importers to strictly follow the regulations for production and quality control. Therefore, when importing plant extracts, it is necessary to have an in-depth understanding of the relevant laws and regulations of the target market, as well as a comprehensive understanding of the product’s production process, quality control and other information. Only by complying with the relevant regulations can we ensure the legality and quality of plant extracts import and export.

🌿 Xi’an Hencegrow Biotechnology Co., Ltd., a professional B2B supplier of plant extracts, we look forward to establishing contact with you, discussing in depth or answering your questions, and providing professional advice to meet your needs and expectations. Thank you! 🤝



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